510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K020354Substantially Equivalent

Baylis Pain Management Generator (Pmg), Models Pmg-115 (Domestic), Pmg-230 (International)

Baylis Medical Co., Inc., Mississauga, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K020354 is the FDA 510(k) clearance record for BAYLIS PAIN MANAGEMENT GENERATOR (PMG), MODELS PMG-115 (DOMESTIC), PMG-230 (INTERNATIONAL), a class II device, cleared for Baylis Medical Co., Inc. on under FDA product code GXD (Generator, Lesion, Radiofrequency). FDA records list 53 510(k) clearances for Baylis Medical Co., Inc., from to . As of , FDA records show no recalls naming K020354.

Clearance record

Decision date
Received
(88 days to decision)
Product code
GXD Generator, Lesion, Radiofrequency
Regulation
21 CFR 882.4400
Device class
Class II
Review panel
Neurology
Applicant
Baylis Medical Co., Inc. 5160 Explorer Dr., Unit 33, Mississauga, Ontario, CA
510(k) summary
Statement
Third party review
No

Clearances, product code GXD

Trailing 12 months

FDA records hold no clearances under product code GXD in the trailing twelve months.

FDA records show no clearances under product code GXD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GXD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260